Vaxil Announces Key US Patent and Trademark Office Notice of Allowance for Its Immunotherapy

TORONTO, ON and REHOVOT, ISRAEL--(Marketwired - August 04, 2016) - VAXIL BIO (TSX VENTURE: VXL),a biotechnology company specializing in immunotherapy, announces today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent providing broad coverage over Vaxil's immunotherapy platform and its lead product, Orphan Drug Designated Immucin™.

This will become the first US Patent issued to Vaxil since the Company began developing its immunotherapies 10 years ago. ImMucin™ is an immunotherapy intended to train a patient's immune system, particularly T-cells and antibodies, to attack cancer cells via a specific domain, called the signal peptide, of the tumor marker MUC1. This domain bears significant advantages as an immunotherapeutic modality including its presence on approximately 90% of all cancer types. The notice indicates the patentability of claims covering the ImMucin™ peptide as well as claims reciting methods for treating or inhibiting cancer using the ImMucin™ peptide.

This is a highly important addition to Vaxil's existing patent portfolio and strengthens the Company's ability to protect its proprietary technologies as it continues rigorous testing and advancement of ImMucin™. Moreover, it positions Vaxil as the only player able to use the 21-mer peptide known as ImMucin™ for all MUC1 positive tumors. Immucin™ is the first product generated from Vaxil's proprietary VaxHit™ platform, and has been awarded Orphan Drug Status from the FDA and EMA. Vaxil believes there is potential for VaxHit™ to generate additional immunotherapy products targeting the signal peptide domains of other prominent tumor markers.

Appointment of New Vice President

Vaxil is also excited to announce a key hire, as Dr. Limor Chen becomes Vice President, focused on advancing operations and clinical affairs. Dr. Chen is a highly experienced scientist, having been a Senior Researcher and Team Leader within the Special Projects Division at Israel's largest pharmaceutical company, Teva. Most recently, Dr. Chen worked as Head of Business Development for an Israeli biotech, which was successful in listing on the NASDAQ. Dr. Chen earned his Ph.D. at Israel's Weizmann Institute of Science, in the laboratory of Prof. Ruth Arnon, the developer of Teva's blockbuster Copaxone against Multiple Sclerosis. He was a Research Fellow at the MD Anderson Cancer Center in Houston, and at the Sunnybrook Research Institute in Toronto.

Vaxil Operations Update

Vaxil is pleased to provide an update on the advancement of core R&D activities during the recent months. The Company has been focused on actively reinvigorating its clinical operations and laboratory in the Weizmann Science Park. Today's announcement marks the Company's third patent secured since listing on the TSX.

Vaxil is prioritizing the formulation of a strategic plan which will most optimally advance its immunotherapy platform and products. Importantly, Vaxil is centering its efforts on developing a strategy intended to both advance its primary Orphan Drug immunotherapy Immucin™ into its critical Phase-II, while at the same time incorporating relevant immunotherapy approaches utilizing the most current developments within the rapidly advancing field. Current factors under consideration range from total number of patients targeted in the upcoming Phase-II, as well as potential combination therapies and companion diagnostic possibilities.

This strategy will focus on driving advancement of the VaxHit™ platform and its ability to generate follow-on products targeting different high-profile cancer antigens. Immucin™, the first offshoot of VaxHit™, demonstrated the platform's ability to target a renowned cancer antigen, in this case MUC1, in an altogether novel manner. While MUC1 is present in approximately 90% of cancer types, Vaxil's Phase-I/II focused on multiple myeloma in order to most effectively demonstrate proof of concept in a traceable blood cancer, one which remains incurable in most cases. ImMucin™ is intended to meet this need in multiple myeloma patients with "minimal residual disease", turning their cancer into a manageable one.

Additionally, Vaxil is developing the first ever antibodies produced against the signal peptide domain of the MUC1 tumor associated antigen, which could become instrumental as a therapeutic and a companion diagnostic product. Current experiments underway will leverage existing data, already utilizing Vaxil's newly acquired lab equipment under the guidance of Dr. Chen. Upon completion of this strategic R&D plan, Vaxil will be in a position to provide greater detail in respect to the proposed structure and timeline of its critical Phase-II trial.

Vaxil has also published a new website in order to better reflect the integrated new Company focused on developing its robust immunotherapy pipeline. This new online presence provides full access to Vaxil's pipeline, patent portfolio, and all medical publications. Visit www.vxlbio.com.

About the VaxHit™Platform and Orphan Drug Designated ImMucin™Lead Product

Vaxil's lead product, the Orphan Drug Designated ImMucin™, trains patients' immune systems to identify and destroy cells through presenting a short specific 21-mer portion (signal peptide domain) of the cancer-associated marker MUC1, which appears on 90% of all cancer cells but not in normal blood cells.

Vaxil completed a Phase I/II clinical study with ImMucin in multiple myeloma patients, and conclusions showed a high safety profile, strong diversified T/B-cell immunity in all 15 patients across MHC repertoires and initial indications of clinical efficacy; 11 out of the 15 treated patients demonstrated stable disease or clinical improvement which did not require any further treatment. An ongoing follow-up study in patients who responded clinically to ImMucin has shown that some patients haven't required any further treatment for their disease up to five years after ImMucin treatment. ImMucin™ was recently granted an Orphan drug designation for MM by both the USA FDA and the European EMA. Results were published in the British Journal of Haematology, available for download at www.vxlbio.com.

About Vaxil

Vaxil is an Israel-Canada-based company specializing in the development of immunotherapy products for the treatment of cancer and infectious diseases by activating the patient's immune system. The company's products are based on the proprietary VaxHit™ technology, which enables the identification of sequences (antigens) in a unique domain of the proteins called the signal peptide that is capable of triggering a unique and specific reaction, among T-cells and antibodies (B-cells) in the immune system of most patients. Recently, Vaxil has reported that by using the VaxHit™ technology, it can identify targets within the same specific domain in proteins, and thus produce improved recombinant antibodies that can serve to diagnose and potentially treat cancer and infectious diseases.

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